MAUDE Adverse Event Report: MSD DEGGENDORF MFG DIVERGENCE¿ ANTERIOR CERVICAL FUSION SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED F

Model Number	G6626527
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a healthcare provider (hcp) via manufacturer representative regarding spinal product that will be used in unknown spinal therapy for cervical disc herniation.It was reported that during anterior cervical fixation, a fracture in the medial-lateral direction of the cage was observed after screw insertion.There were no broken fragments left inside the patient and no further complications or symptoms were reported.Additional information was received via manufacturer representative that the crack was found after the cage was inserted.The issue occurred during normal use.
Additional Manufacturer Narrative
G2: country of origin is (b)(6).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
H3: product analysis of part# g6626527, lot# h5780479 visual and optical inspection revealed the implant was returned damaged.The implant has cracked next to where the release/lock mechanism is.The implant is fragile and can be overloaded.It appears the implants structural integrity was overloaded during the implantation procedure.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: DIVERGENCE¿ ANTERIOR CERVICAL FUSION SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED F
• Manufacturer (Section D): MSD DEGGENDORF MFG; wertstrasse 17; deggendorf 94469 ; GM 94469
• Manufacturer (Section G): MSD DEGGENDORF MFG; wertstrasse 17; deggendorf 94469 ; GM 94469
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 20155057
• Report Number: 1030489-2024-01093
• Device Sequence Number: 8301619
• Product Code: OVE
• UDI-Device Identifier: 00643169337435
• UDI-Public: 00643169337435
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141599
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G6626527
• Device Catalogue Number: G6626527
• Device Lot Number: H5780479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2024
• Supplement Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown